GI-Challenge Study for Gastroparesis Patients and Healthy Controls

NCT03896126 | Terminated DMC

• 1 other identifier: 44258
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroparesis Patients and Healthy Controls ages 20-49 will be asked to participate in an observational study measuring vagal activity following food ingestion in order to establish parameters of autonomic nerve/vagal function in healthy human subjects compared to those with gastroparesis. Information generated from this study may be used in the future to establish what is normal and abnormal enteric vagal tone and how much vagal nerve stimulation treatment may be required to help patients with gastroparesis.

Conditions

Gastroparesis

Keywords

Healthy Control; Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (3)

• Determination of sympathovagal score, a measure of cardiac autonomic activity, following digestive challenges in healthy volunteers using the FDA-approved ANSAR ANX 3.0 Autonomic Nervous System (ANS) Monitoring System.

  The ANSAR computes sympathovagal score by collecting sympathetic low frequency area (LFa) and parasympathetic respiratory frequency area (RFa) data (both measured as beats per minute squared, or BPM2) and calculating the ratio of these two complementary measures of the autonomic nervous system (LFa/RFa) to arrive at one aggregated score.

  Single two hour visit

• Determination of sympathovagal score following digestive challenges in gastroparesis patients using the ANSAR ANX 3.0 ANS Monitoring System and comparison to healthy volunteers.

  The ANSAR computes sympathovagal score by collecting sympathetic low frequency area (LFa) and parasympathetic respiratory frequency area (RFa) data (both measured as beats per minute squared, or BPM2) and calculating the ratio of these two complementary measures of the autonomic nervous system (LFa/RFa) to arrive at one aggregated score.

  Single two hour visit

• Correlation of sympathovagal score, a measure of cardiac autonomic activity, with gastroparesis disease severity.

  To determine if sympathovagal scores correlate with gastroparesis clinical disease severity using standardized GI symptom scoring - the Gastroparesis Cardinal Symptom Index consists of 10 questions that rate gastroparesis symptoms on a scale of 1 - 6 from "none" to "very severe".

  Single two hour visit

Study Arms (2)

Gastroparesis Patients

20 gastroparesis patient ages 20-49

Other: Observational

Healthy Controls

40 healthy controls ages 20-49

Other: Observational

Interventions

Observational OTHER

There is no intervention. This is an observational study attempting to establish parameters of normal and abnormal vagal tone in healthy control and gastroparesis patients, as there is currently no metric to determine what dose of vagal stimulation is required to treat gastroparesis.

Gastroparesis Patients; Healthy Controls

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

60 Patients (20 Gastroparesis and 40 Controls) between the ages of 20-49.

You may qualify if:

• Male or female.
• Age 20-49 years old.
• Healthy volunteer or established diagnosis of idiopathic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
• Participant is capable of giving informed consent.
• Gastroparesis patients must be on stable doses of medications for gastroparesis for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).

You may not qualify if:

• Diagnosis of systemic autonomic nerve dysfunction (i.e. POTS, CAN).
• Surgical-related gastroparesis
• Extrinsic myopathy or neuropathy causing gastroparesis.
• Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
• Patients with enteric feeding tubes or requiring parenteral nutrition.
• Patients with severe disease flare requiring hospitalization or frequent emergency room visits (last within 3 months or less of enrollment).
• Untreated significant depression or suicidal thoughts.
• Pregnant or breast-feeding women.
• History of gastric pacemaker implantation.
• Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, pyloroplasty, or gastric bypass.
• Patients with implantable electronic devices.
• Dairy, wheat, or egg allergy/intolerance.
• Allergy to commercial clinical adhesive for EKG stickers.
• Non-English speaker and/or hearing impaired (as participants need to follow English verbal commands and cues for the experiment).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Andres C Gottfried Blackmore, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Linda Nguyen, MD

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor - Medicine/Gastroenterology and Hepatology

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 29, 2019
• Study Start: January 1, 2019
• Primary Completion: November 2, 2023
• Study Completion: August 18, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)